Table 2.
Incidence of grade ≥3 AEs
System organ class MedDRA preferred term |
Danvatirsen monotherapy (cohort 1) N=5 | Danvatirsen+durvalumab (cohort 2) N=6 |
Patients with any AE | 3 (60.0) | 6 (100.0) |
Metabolism and nutrition disorders | 2 (40.0) | 1 (16.7) |
Hypermagnesaemia | 1 (20.0) | 0 |
Hypertriglyceridaemia | 0 | 1 (16.7) |
Hypokalaemia | 1 (20.0) | 0 |
Gastrointestinal disorders | 1 (20.0) | 0 |
Pancreatitis | 1 (20.0) | 0 |
Hepatobiliary disorders | 0 | 2 (33.3) |
Hepatic function abnormal (ALT/AST/γGT increased) | 0 | 2 (33.3) |
Investigations | 1 (20.0) | 3 (50.0) |
Neutrophil count decreased | 0 | 2 (33.3) |
ALT increased | 1 (20.0) | 0 |
AST increased | 1 (20.0) | 0 |
Blood bilirubin increased | 1 (20.0) | 0 |
γGT increased | 1 (20.0) | 1 (16.7) |
Platelet count decreased | 0 | 1 (16.7) |
Data are n (%).
AE, adverse event; ALT, alanine aminotransferase; AST, aspartate aminotransferase; γGT, gamma-glutamyl transferase.